Model Number N/A |
Device Problem
Calibration Problem (2890)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Udi number: (b)(4).Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
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Event Description
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It was reported that the torque output of four torque limiting handles were found outside of the adequate performance range.This was detected during a preliminary calibration check by zimmer biomet spine personnel.There are no specific surgical procedures associated with these handles.This is report four of four for this event.
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Manufacturer Narrative
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Additional information: (method, results, conclusions) - the returned device was evaluated.The torque output was confirmed to be outside of the range.There were no signs of abnormal wear found.Handles found out of calibration typically exhibit spring relaxation, wear of critical torque components, and/or break down of the internal lubrication from use over time.A review of the manufacturing records did not identify any issues which may have contributed to this event.
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Event Description
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It was reported that the torque output of four torque limiting handles were found outside of the adequate performance range.This was detected during a preliminary calibration check by zimmer biomet spine personnel.There are no specific surgical procedures associated with these handles.This is report four of four for this event.
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Search Alerts/Recalls
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